Spots Global Cancer Trial Database for A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation
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Trial Identification
Brief Title: A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation
Official Title: A Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.
Study ID: NCT01572727
Conditions
Study Description
Brief Summary: This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.
Detailed Description: Based on the efficacy results at the time of the interim analyses, the DMC recommended stopping the study at Phase II during the interim as it met the protocol pre-specified futility criteria. Consequently, the Phase III portion of the study was not conducted.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Ironwood Cancer and Research Centers SC, Chandler, Arizona, United States
Arizona Oncology Associates Dept of Oncology, Phoenix, Arizona, United States
Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas, United States
California Cancer Care Marian Speciality, Greenbrae, California, United States
Rocky Mountain Cancer Centers RMCC Hale Pkwy, Greenwood Village, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute SC, Tampa, Florida, United States
Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2), Atlanta, Georgia, United States
Northwest Georgia Oncology Center NW Georgia Onc, Marietta, Georgia, United States
University of Kansas Cancer Center Univ Kansas 2, Kansas City, Kansas, United States
Norton Healthcare, Inc., Louisville, Kentucky, United States
Washington University School of Medicine Regulatory, St. Louis, Missouri, United States
University of Nebraska Medical Center Unv Nebraska Med Ctr (2), Omaha, Nebraska, United States
University of New Mexico Cancer Research Center Dept of Univ New Mexico, Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C. Dept. of New York Oncology. PC, Troy, New York, United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-1, Columbus, Ohio, United States
University of Oklahoma Health Sciences Center OUHSC 2, Oklahoma City, Oklahoma, United States
Northwest Cancer Specialists Vancouver Loc, Portland, Oregon, United States
Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology, Dallas, Texas, United States
University of Texas Southwestern Medical Center Harry Hines, Dallas, Texas, United States
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio, San Antonio, Texas, United States
Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VA, Reston, Virginia, United States
Novartis Investigative Site, Sydney, New South Wales, Australia
Novartis Investigative Site, Geelong, Victoria, Australia
Novartis Investigative Site, Parkville, Victoria, Australia
Novartis Investigative Site, Nedlands, Western Australia, Australia
Novartis Investigative Site, Salzburg, , Austria
Novartis Investigative Site, Vienna, , Austria
Novartis Investigative Site, Charleroi, , Belgium
Novartis Investigative Site, Liege, , Belgium
Novartis Investigative Site, Liège, , Belgium
Novartis Investigative Site, Ottignies, , Belgium
Novartis Investigative Site, Sint-Niklaas, , Belgium
Novartis Investigative Site, Wilrijk, , Belgium
Novartis Investigative Site, Fortaleza, CE, Brazil
Novartis Investigative Site, São Paulo, SP, Brazil
Novartis Investigative Site, São Paulo, SP, Brazil
Novartis Investigative Site, São Paulo, SP, Brazil
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Brno, , Czech Republic
Novartis Investigative Site, Olomouc, , Czech Republic
Novartis Investigative Site, Praha 2, , Czech Republic
Novartis Investigative Site, Angers Cedex 02, , France
Novartis Investigative Site, Bordeaux, , France
Novartis Investigative Site, Creteil, , France
Novartis Investigative Site, La Roche sur Yon cedex 9, , France
Novartis Investigative Site, Le Mans Cedex, , France
Novartis Investigative Site, Marseille, , France
Novartis Investigative Site, Nice Cedex 2, , France
Novartis Investigative Site, Saint Herblain cedex, , France
Novartis Investigative Site, Toulouse Cedex 9, , France
Novartis Investigative Site, Villejuif Cedex, , France
Novartis Investigative Site, Bonn, , Germany
Novartis Investigative Site, Dresden, , Germany
Novartis Investigative Site, Erlangen, , Germany
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Fulda, , Germany
Novartis Investigative Site, Mainz, , Germany
Novartis Investigative Site, Muenchen, , Germany
Novartis Investigative Site, Ravensburg, , Germany
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Hong Kong SAR, , Hong Kong
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Debrecen, , Hungary
Novartis Investigative Site, Szolnok, , Hungary
Novartis Investigative Site, Ramat Gan, , Israel
Novartis Investigative Site, Tel Aviv, , Israel
Novartis Investigative Site, Cona, FE, Italy
Novartis Investigative Site, Genova, GE, Italy
Novartis Investigative Site, Monza, MB, Italy
Novartis Investigative Site, Messina, ME, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Nagoya-city, Aichi, Japan
Novartis Investigative Site, Nagoya, Aichi, Japan
Novartis Investigative Site, Sapporo, Hokkaido, Japan
Novartis Investigative Site, Isehara-city, Kanagawa, Japan
Novartis Investigative Site, Kawasaki-city, Kanagawa, Japan
Novartis Investigative Site, Yokohama, Kanagawa, Japan
Novartis Investigative Site, Kumamoto City, Kumamoto, Japan
Novartis Investigative Site, Suita-city, Osaka, Japan
Novartis Investigative Site, Koto, Tokyo, Japan
Novartis Investigative Site, Osaka, , Japan
Novartis Investigative Site, Osaka, , Japan
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Breda, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, St.- Petersburg, Russia, Russian Federation
Novartis Investigative Site, St. Petersburg, , Russian Federation
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Johannesburg, , South Africa
Novartis Investigative Site, Cordoba, Andalucia, Spain
Novartis Investigative Site, Malaga, Andalucia, Spain
Novartis Investigative Site, Sevilla, Andalucia, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, A Coruna, Galicia, Spain
Novartis Investigative Site, La Laguna, Santa Cruz de Tenerife, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Zaragoza, , Spain
Novartis Investigative Site, Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan
Novartis Investigative Site, New Taipei City, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Maidstone, Kent, United Kingdom
Novartis Investigative Site, Glasgow - Scotland, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Wirral, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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